ORIGINATOR: President

SUBJECT: Conflict of Interest: Identification and Management of Conflicts for PHS/NSF Sponsored Activities

General
Effective October 1, 1995 all proposals and renewal applications being submitted to the Public Health Service (PHS) (including all its institutes) or the National Science Foundation (NSF) are required to include a certification by UMUC authorizing officials that UMUC has implemented and is enforcing a written policy on conflicts of interest. In addition to existing University of Maryland System and UMUC policies on professional commitment of faculty, outside consultancy, and conflict of interest, the following policy and procedures apply to actual or potential conflicts of interest arising from activities sponsored by PHS and NSF. These federal agencies have promulgated regulations which require:

investigators to disclose certain financial interests;

institutional review of these disclosures;

designation of a person(s) to review the disclosures, identify conflicting interest, and take actions necessary to ensure that such conflicting interest will be managed, reduced or eliminated;

arrangements for informing (a) the NSF of conflicts that are not resolved to the satisfaction of UMUC and (b) the PHS of all conflicts reported, resolved or not; and

record retention procedures. Subcontractors and collaborators must either comply with UMUC's policy or provide assurance to UMUC that they comply with their own policies that meet the PHS and/or NSF requirements, as applicable.

Definitions

"Investigator" means the principal investigator, co-principal investigator(s), and any other person employed by or working under the auspices of UMUC who has independent responsibility for the design, conduct, or reporting of research or educational activities funded or proposed for funding by PHS or NSF. (This may include persons working under the Principal Investigator.) These individuals are those who have independent responsibility for accomplishing project objectives. For purposes of the requirements relating to financial interests, "investigator" includes the investigator's spouse and dependent children.

"Significant financial interest" means anything of monetary value, including but not limited to salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g. stocks, stock options, or other ownership interests); and intellectual property rights (e.g. patents, copyrights, and royalties from such rights.) The term does not include:

salary, royalties, or other remuneration from UMUC;

income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;

income from service on advisory committees or review panels for public or nonprofit entities;

an equity interest that when aggregated for the investigator and the investigator's spouse and dependent children, meets both of the following tests: (a) does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and (b) does not represent more than 5% ownership interest in any single entity; or

salary, royalties, or other payments that, when aggregated for the investigator and the investigator's spouse and dependent children, are not expected to exceed $10,000 during the next twelve month period.

"Conflict of interest" means, for the purpose of these procedures, any significant financial interest of the investigator and the investigator's spouse and dependent children that could directly and significantly affect the design, conduct or reporting of PHS or NSF funded research, as reasonably determined by UMUC.

"Reportable Significant Financial Interest" means a Significant Financial Interest (i) that would reasonably appear to be affected by the research and educational activities funded or proposed for funding by PHS or NSF of (ii) in entities whose financial interests would reasonably appear to be affected by such activities.

"Research" means a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses, for example, basic and applied research, product evaluation, testing, development, and clinical trials. As used in these Procedures, the term includes any such activity for which research funding is available from a component of the PHS through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, and any such activity for which research funding or any educational activity is available from the NSF.

Disclosure Requirements

An investigator seeking or holding PHS or NSF funding must disclose any reportable significant financial interest.

An investigator seeking PHS or NSF funding who has no reportable significant financial interest to disclose must so indicate by checking the appropriate statement and signing the Proposal Routing and Approval Form which accompanies the proposal.

An investigator seeking PHS or NSF funding who has a reportable significant financial interest to disclose must so indicate on the Proposal Routing and Approval Form and must complete the "Investigator Financial Disclosure Statement for PHS/NSF Proposals". This form and any supporting documentation must be submitted with (or in advance of) the proposal. This form is available in the Office of Professional Development or in Financial Affairs.

All disclosures must be updated during the period of the award on an annual basis or as new reportable significant financial interest are obtained by completing and routing the Update/Annual Certification for PHS/NSF Sponsored Activities. Each investigator must complete this form, which is available in the Office of Professional Development or in Financial Affairs.

Institutional Review Process

The investigator's unit head is responsible for conducting the initial review of disclosures submitted by investigator(s) within that supervisor's unit. The unit head, subject to UMUC 's review and final decision, will determine what reportable significant interests are conflicts of interest (as defined above) and what mechanisms are appropriate for managing, reducing, or eliminating real or potential conflicts of interest. Examples of conditions or restrictions that might be imposed include:

public disclosure of significant financial interests

monitoring of research by independent reviewers

modification of the research plan

disqualification from participation in the portion of funded research that could be affected by the significant financial interests

divestiture of significant financial interests

severance of relationships that create actual or potential conflicts.

Disclosure of conflicts and the resolution or plan for resolution shall be forwarded from the unit head, through intermediate supervisors as required, to the Vice President to whom such unit head reports. Following action by the Vice President, the disclosure and resolution or plan for resolution shall be forwarded to the Assistant Vice President, Financial Affairs.

Should a reportable significant financial interest or a conflict of interest resulting from a reportable significant financial interest remain unrecognized through the proposal routing process, the office that recognizes the conflict will contact the Assistant Vice President, Financial Affairs or the Vice President for Academic Affairs. The Assistant Vice President, Financial Affairs will contact the investigator for additional information.

If the Assistant Vice President, Financial Affairs finds that a disclosure of a reportable significant financial interest has revealed a conflict of interest that is unresolved after the initial review(s) and the subsequent review of the academic dean, or if the Assistant Vice President, Financial Affairs finds that a recommended plan for resolution is inconsistent with UMUC guidelines, the Assistant Vice President, Financial Affairs will forward the matter to UMUC's Conflict of Interest Advisory Committee for consideration. The Committee will examine the matter and make its recommendations to the Vice President for Academic Affairs, who will make a decision on behalf of UMUC. A faculty member dissatisfied with the final action of the Vice President for Academic Affairs may appeal to the President of UMUC, who, at his discretion, may reconsider the matter for UMUC.

Proposals will not be forwarded to PHS or NSF by UMUC until the conflict of interest review process has reached the level of the Assistant Vice President, Financial Affairs. A proposal may be forwarded to PHS or NSF by UMUC before the review process is completed, but (1) no funds can be spent for the project until the process is completed, and (2) the proposal will be withdrawn if it is determined that an identified conflict of interest cannot be eliminated or managed. If a proposal has been forwarded on the expectation that an approved plan for resolution of conflict of interest will be implemented, the identified conflict must be satisfactorily managed, reduced or eliminated prior to UMUC's expenditure of any funds under the award for the project affected. If the conflict cannot be satisfactorily resolved, the grant proposal may be withdrawn or the award declined.

For on-going projects, conflicts disclosed subsequent to UMUC's initial report to PHS or NSF under an award must be resolved, at least on an interim basis, within sixty (60) days after the identification of the potential conflict by UMUC.

Reporting Procedures and Record Retention

The Assistant Vice President, Financial Affairs is responsible for providing the appropriate written notice to the awarding agency. Conflicts which cannot be satisfactorily resolved must be disclosed to PHS and NSF. In the case of PHS awards, notice must be given for all conflicts of interest.

The Assistant Vice President, Financial Affairs will maintain records of all financial disclosures and of all actions taken to resolve actual or potential conflicts of interest at least three (3) years after termination or completion of the sponsored project or after resolution of any government action involving those records, whichever is longer.

As required by federal agency regulations, information regarding all conflicts of interest identified to or by UMUC will be made available to the federal government upon request. The NSF Office of General Counsel will be appropriately informed if UMUC finds that it is unable to satisfactorily manage a Conflict of Interest related to NSF reported research.

Compliance

Non-compliance could result in the termination of the sponsored activity and/or restriction on the individual with respect to proposal submissions as well as other appropriate sanctions that would be provided by University of Maryland System and UMUC policies and procedures, the Maryland Public Ethics Law, and federal laws regulations.

If the failure of an Investigator to comply with UMUC conflict of interest policy has biased the design, conduct, or reporting of the PHS-funded research, UMUC must promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action or refer the matter to UMUC for further action, which may include directions to UMUC on how to maintain appropriate objectivity in the funded project.

Confidentiality
Information submitted by investigators with respect to reportable, significant financial interests and/or identified conflicts of interest shall be treated as personal information under the Maryland Access to Public Records Law, and shall be disclosed by UMUC only as permitted by State law or otherwise required by law or court order. This limitation shall not apply to information which is required to be disclosed as part of the steps to manage a potential or actual conflict of interest.